Technical data sheet Product description The device is used for obtaining full-thickness skin specimen for the biopsy test. 2460 Product charasteristics • Sterile product by Gamma irradiation. • Shelf life: 5 years upon the manufacturing date. B Materials • Tip: Stainless Steel. • Handle: ABS. . CAP: LDPE. • Primary packaging: Medical grade. B Main dimensional properties • BPS10: 1 mm diameter. • BPS20 : 2 mm diameter. • BPS30: 3 mm diameter. • BPS40: 4 mm diameter. • BPS50: 5 mm diameter. • BPS60: 6 mm diameter. • BPS70: 7 mm diameter. • BPS80: 8 mm diameter. This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 1 - 3

Technical data sheet B Biocompatibility • ISO 10993-5: No cytotoxic. • ISO 10993-4: Hemocompatible. • ISO 10993-10: No sensitizing. • ISO 10993-10: Negative intracutaneous irritation test. Conclusion: product is biocompatible. B Storage and maintenance • Keep protected from direct sunlight / the outside. • Keep in a dry place. • Temperature range: 10°C - 40°C. • Single use product. No maintenance required. B Packaging # Ref Packaging BPS10 BPS1.0 Individual pouch, in case of 10 units. BPS20 BPS2.0 Individual pouch, in case of 10 units. BPS30 BPS3.0 Individual pouch, in case of 10 units. BPS40...

TECHNICAL DATA SHEET Regulatory informa on TELIC, S.A.U. guarantees that this product is in conformity with Direc ve 93/42/EEC and that it has been manufactured following the direc ves of the Quality Assurance System cer fied as ISO 13485. This product is classified as: Class IIa product according to Annex IX of Direc ve 93/42/EEC, rule 6. GMDN code: 35286. This document is the property of Telic, S.A.U. Transmission to third-par es or non-authorized copies are not allowed 3-3